Physiological requirements vary from individual to individual and even within an individual during the course of a lifetime. Further, various conditions may effect physiological requirements. For example, pregnant, lactating and menopausal women may have enhanced needs for certain nutrients, therapeutic agents or treatments and reduced needs, or even tolerance, for other nutrients, therapeutic agents or treatments. Meeting the specific physiological requirements of humans and other animals may require the use of a complex daily therapeutic regimen requiring administration of various biologically-active substances at different times during the day.
A WHO study estimates that only 50% of patients suffering from chronic diseases in developed countries follow treatment recommendations. This may affect patient health, and affect the wider society when it causes complications from chronic diseases, formation of resistant infections, or untreated psychiatric illness.
There are a broad range of factors which play a role in poor patient compliance, including complexity of regimen, instructions for administration not clear, purpose of treatment not clear, forgetfulness and physical difficulty in complying, e.g. opening medicine containers.
This compliance problem is further compounded where the treatment regime is complex, requiring multiple doses per day or treatment period or requiring different doses of a combination of drugs. Avoidance of rigorous medication schedules can lead to decreased efficacy of the therapeutic treatment. Conversely, careless administration of medications can increase the severity of undesirable side effects and the exposure to unwarranted safety risks, including death.
Disposable pharmaceutical containers for dispensing medicaments which are used to help patients improving compliance to a medical treatment have been previously disclosed.
In order to help patients improving compliance and turn it into a patient adherence to the treatment one common approach uses indicia embossed or printed on the blister package.
US 2007015728 provides a metered-dose package for co-administration of a first and a second component of a therapeutic agent. The metered-dose package includes a first plurality of fluidly not-communicating chambers, each chamber containing an individual dose of the first component, and a second plurality of chambers, each said chamber capable of reversibly receiving at least one dose of the second component.
U.S. Pat. No. 6,375,956 relates to a disposable dispensing apparatus which provides optimal therapeutic support to humans and other animals by conveniently supplying a complex dosing regimen requiring simultaneous administration of storage-incompatible or unevenly dosed components in a shelf stable user-friendly format.
WO04089274 refers to a drug packaging, or kit, or presentation facilitating self administration of drugs by the patients, which is characterized by comprising one or more blister cards, featuring patient instruction in print form with regard to the dosage of each unit, type or mature of the active ingredient, period of the day to be taken and treatment period, among other information.
US 2004266745 discloses a blister pack for a preparations useful in hormone replacement therapy, on which a system facilitating the alternative administration of daily dosage unit, preferably as a scheme using integers from 1 to 28 to record the sequence of the particular dosage unit to be administered each day.
US2007015839 discloses a daily drug regimen for treating metabolic syndromes in a single package. The package includes doses to be taken at two different times of the day. The package can include a single day's regiment, or can include multiple days' regiment.
To help patients improving adherence to a medical treatment other approaches have been disclosed.
U.S. Pat. No. 4,627,432 relates to a device for administering medicaments to patients comprising a cylindrical chamber including a support to support a blister pack. Blisters are located in holes in the support. A plunger is arranged to enter the chamber and open a blister registered with it. When the blister is opened, medicament can be withdrawn by a patient.
U.S. Pat. No. 4,850,489 relates to dispensing packs which contain chambers with at least two solid, not mechanically connected dosage units. Where it is necessary the two pharmaceutical contained can be release at delayed intervals.
US2001030140A discloses a blister package for a pharmaceutical treatment having a plurality of individual blisters suitable for containing a pre-measured dosage of a pharmaceutical composition in the form of tablets, pills and capsules. In accordance with a pre-determined schedule of administration sealed blisters may be opened by a method of tearing, peeling and pushing.
U.S. Pat. No. 4,889,238 relates to a medicament package for improving compliance with a therapeutic regimen. The therapeutic regimen involves a plurality of medications administered to a patient in a prescribed sequence and in accordance with specified intervals. The package includes a multiplicity of blister cards carrying the medicaments in sequential order on the individual cards and from card to card. The blister cards being placed in stacked array with the principal dimensions thereof oriented generally horizontally and arranged in order of use with the first to be used topmost. Also included is a base which houses the stack of blister cards and is adapted to support the stack vertically and provides lateral support to the edges of the blister cards. The base permits direct and unobstructed access to the uppermost blister card and limited access only to the edges of the blister cards. A lid is adapted to cover the base and movable to an open position allowing access to the uppermost blister card. Each blister card generally contains indicia denoting the order and sequence when the contents of a particular blister recess are to be consumed.
WO9822072A describes a pharmaceutical package for aiding or increasing patient compliance for the administration of a specific pharmaceutical drug regimen, comprising: a) at least one blister card divided into sections separating each complex drug regimen dose; each dose comprising an indicia denoting the time in which the dose is to be administered; b) a patient information booklet comprising dosing information; c) a daily calendar comprising dosing information; and d) a reminder aid.
U.S. Pat. No. 4,254,871 relates to a packaging element for mounting blister strips containing a course of medication for a patient. The element comprises a foldable lamina divided into a supporting and a backing member with the element characterized by a plurality of apertures for receiving blisters strips. The lamina is marked to show the day of administration for the contents of each strip to improve patient compliance.
WO 03079959 relates to a tablet box for receiving and extracting tablets in a controlled manner. A commercially available blister pack can be placed directly in the tablet box, which is provided with an alarm display for the extraction of the tablets.
US 2002162769 discloses a pre-packaged, therapeutic regimen including two dosage units. Indicia for distinguishing between the first and second dosage units, administration instructions that teach the coordinated use of the dosage units, are included in the disclosed a pharmaceutical dispensing container.
EP1502568 relates to an assembly for dispensing pharmaceutical products comprising perforated plates within a housing, combined with an electronic box, where a blister pack is placed in the assembly, which lies on contacts to close a circuit and a perforated swing blade acts as a cover and blocks the blisters of the pack selectively, is new. An acoustic and visual alarm is triggered at the same time each day, according to the instructions carried by the blister pack to remind to the patient to follow the regiment.
The above discussed holders, dispensers and pharmaceutical packages are deficient in several aspects. Significantly, none of the above references present a convenient, simple and effective way of facilitating the selective access and therefore administration of substances, particularly when said substances are taken as part of a complex sequential time dependent therapeutic regimen. Further, none of the above references specifically addresses a way to facilitate simultaneous administration of prescription and non-prescription substances as part of a complex regimen. Moreover, none of the above references addresses the issue of optimizing a pharmaceutical package and helps patients improving adherence to a medical treatment. Therefore, there remains a need for a simple, inexpensive and convenient means for providing optimal therapeutic support for humans and other animals, and in particular for providing optimal support for humans and other animals having special therapeutic needs.
In addition, none of the prior art solves the problem of safety compliance in packaging. None of the prior art provides a solution to the problem of involuntary wrong uptaking of medicine, e.g. patients may access and therefore uptake drugs in a wrong sequential order.
Thus, there exists a need for a simple and effective system that increases safety and efficacy in compliance through imposition of prescribed doses at prescribed intervals for medications within a therapeutic regimen.